LAKIS: Levosimendan in Acute Kidney Injury Study

Sponsor

VieCuri Medical Centre (Other)

Overall Status

Unknown status

CT.gov ID

NCT01720030

Collaborator

Orion Corporation, Orion Pharma (Industry)

Enrollment

Location

Arms

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We hypothesise that levosimendan will have a positive influence on renal function during acute kidney injury in adult intensive care patients.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Drug: Levosimendan Drug: Conventional therapy	Phase 2/Phase 3

Detailed Description

The purpose of this trial is to evaluate whether the use of levosimendan is able to improve renal function.

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Prospective, Randomized, Monocenter, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Levosimendan in Intensive Care Patients With Acute Kidney Injury

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2017

Anticipated Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Conventional therapy Standard of care as protocolized locally	Drug: Conventional therapy Placebo therapy to safeguard blinding Other Names: Standard care plus placebo comparator
Experimental: Levosimendan The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI.	Drug: Levosimendan Verum therapy Other Names: Simdax (R)

Arm

Intervention/Treatment

Placebo Comparator: Conventional therapy

Standard of care as protocolized locally

Drug: Conventional therapy

Placebo therapy to safeguard blinding

Other Names:

Standard care plus placebo comparator

Experimental: Levosimendan

The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI.

Drug: Levosimendan

Verum therapy

Other Names:

Simdax (R)

Outcome Measures

Primary Outcome Measures

Change in renal function [Baseline and every 24 hours until end ICU stay]
Daily analysis of kidney function expressed in endogenous creatinine clearance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinically diagnosed adult patients with AKI

Exclusion Criteria:

Failure to obtain written consent to participate from patient or legal representative (by deferred consent)
Patients entering the ICU for post-operative observation with an estimated length of stay less than 24 hrs.
Moribund patients
Patients under the age of 18
Pregnancy
Patients suffering from pre-existing renal failure (elevated NGAL values without apparent rise in creatinine values)
Renal replacement therapy initiated before admission due to Chronic Kidney Disease
Hypersensitivity to levosimendan experienced by previous treatments
Severe hypotension and tachycardia
Significant mechanical obstruction affecting ventricular filling or outflow or both.
Severe hepatic impairment (ALAT/ASAT>400U/L)
Patients will be excluded if the treating physician judges that study participation is undesirable for medical, medical-ethical or other reasons
Known history of Torsades de Pointes